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Lab & Testing Services

Please contact our Client Care for the most up-to-date information on our testing services and for assistance with submitting a sample via EagleTrax.  We look forward to serving you.

Microbiology Tests

Test Time*

Price

ScanRDI® Sterility Test 2 business days $299
ScanRDI Method Suitability Test (required on file) 7 business days $1,750
BacT/Alert Sterility Test 8 – 10 business days Call for Pricing
BacT/Alert Sterility Test Method Suitability (required on file) 8 – 10 business days $1,000
USP <71> Sterility Test 14-18 business days $125
USP <71> Sterility (Daily Read) 14-18 business days $299
USP <71> Sterility (Direct Inoculation) 14-18 business days $275
USP <71> Method Suitability Test (required on file) 7 business days $400
USP <85> Bacterial Endotoxin Test (Turbidimetric) 2 business days $99
USP <85> Bacterial Endotoxin Method Validation 7 business days $450

USP <85> Endotoxin Oven Validation

Minimum of 1 control must be provided.

5 business days $99/vial
USP <51> Anti-Microbial Effectiveness (AME) Test 35 days $1,000
USP <51> Method Suitability Test (required on file) 14 days $1,000
USP <60> Burkholderia Cepacia Complex 5 business days $175
USP <60> Burkholderia Cepacia Complex Method Suitability (required on file) 7 business days $750
USP <61> Microbial Enumeration Test 7 business days $225
USP <61> Method Suitability Test (required on file) 7 business days $799
USP <62> Objectionable Organisms 7 business days $125/organism
USP <62> Method Suitability Test (required on file) 7 business days $250/organism
USP <788> or USP <789> Particulate Count Test 5 business days $199
USP <790> Visual Particulate 3 business days $99
USP <1207> Container Closure Integrity Test (Utilizing the “Pressure Decay” Method) 5 business days $550
USP <1207> Container Closure Integrity Test (Utilizing the “Dye Ingress” Method) 5 business days Call for Pricing
USP <1231> Water for Pharmaceutical Purposes 4 business days $195
USP <55> Biological Indicator (Spore Count) 10 business days $350
Biological Indicator (Spore Strips, Ampoules, Dry Ampoules) 10 business days $75/unit
Growth Promotion 10 business days $275
Incubation 10 business days $15
Media Fill 18 business days $50 + $1.50/vial
Microbial Identification 10 business days $175/CFU
Plate Enumeration 10 business days $35

 

Chemistry Tests

Delays in analysis and/or additional costs may occur if the formula worksheet is not submitted, or if Eagle does not have current developed protocols for the active ingredient(s) present in the sample.

Test Time*

Price

Potency Test

Uses the advanced HPLC/UHPLC and Spectrographic instrumentation. Protocols have been developed based on USP <621> and <851> methodology.

Potency – Solutions (aqueous-based)

Potency – Non-solution (capsules, gels, suspensions, creams, animal treats, powder aliquots, suppositories, troche, tablets, etc.)

 

 

 

 

$175/active

$225/active

    1-3 Actives 4 business days  
    4+ Actives 7 business days  
    Solid dosage forms: 1-3 Actives 5 business days  
    Solid dosage forms: 4+ Actives 7 business days  
HCG 7 business days $1,000
USP <281> Residue on Ignition 5 business days $350
USP <643> Total Organic Carbon 10 business days $200
USP <645> Water Conductivity 10 business days $100
USP <731> Loss on Drying 5 business days $200
USP <741> Melting Range 5 business days $225
USP <781> Optical Rotation 5 business days $285
USP<785> Osmolality & Osmolarity 10 business days $250
USP <800> Environmental Swab Testing 5 business days $225
USP <905> Uniformity of Dosage 5 business days $725
USP <921> Water Content Determination 5 business days $145
Appearance 5 business days $35
Identification 5 business days $299
pH 2 business days $35
Raw Material Assay 5 business days $525
Raw Material ID 5 business days $299

 

Additional Services

Test Time*

Price

Method Verification & Validation 4 – 6 weeks $5,500 1st active, $3,500 each additional active
New Method Development 4 – 6 weeks $7,750 1st active, $5,500 each additional active
Stability Studies TBD Call for Quote
USP Monograph Testing TBD Call for Quote

ADDITIONAL TESTING SERVICES

We offer additional testing services not listed on this document. Call the Eagle Client Care Team at 832.295.1276 for more information.

*Testing begins 1 business day after sample is received.

*RUSH Service available for double the regular test price.

*SUPER RUSH Service available for triple the regular test price. Call for details. 

Please note: A $50 cancellation fee will be assessed if cancellation is requested after samples have arrived at our facility. If testing has been initiated, the full price of the test will be charged.

All pricing is in USD and subject to change at any time.

View Minimum Sample Requirements (PDF)

USP <51> Antimicrobial Effectiveness:

Sterile articles packaged in multi-dose containers must be free of microorganisms throughout their entire shelf-life. Due to the potential for the introduction of microorganisms through the repeated withdrawal of individual doses, sterile products that are packaged in mutli-dose containers should contain an antimicrobial preservative. However, the concentration of an added antimicrobial preservative can be kept to a minimum if the ingredients of the compounded formulation possess an intrinsic antimicrobial activity. Antimicrobial effectiveness, whether inherent in the product or as a result of an antimicrobial preservative, must be demonstrated through USP <51> antimicrobial effectiveness testing. 

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USP <61> Microbial Enumeration Test:

As the presence of microorganisms in nonsterile preparations has the potential to reduce and/or inactivate therapeutic activity and adversely affect the health of patients, compounders are required to ensure that nonsterile preparations have a low bioburden that complies with established specifications for microbiological quality as outlined in USP <61>. USP <61> Microbial Enumeration tests provide a quantitative evaluation of a product’s microbial content to demonstrate compliance with established specifications.

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USP <62> Tests for Specific Microorganisms:

Table 1 in USP <1111> sets acceptance criteria for the presence of certain microorganisms in a nonsterile preparation based on its route of administration. The presence of these objectionable pathogens and microorganisms cannot exceed the acceptance criteria outlined in Table 1. USP <62> testing is designed to demonstrate compliance with these requirements by quantifying the presence of specified microorganisms.

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USP <71> Sterility Testing:

USP <71> outlines the compendial requirements for sterility testing that must be followed in order to be able to claim that the results of the test provide evidence that the product is sterile. 

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USP <71> Method Suitability Testing:

USP <71> Method Suitability Testing (MST) must be performed prior to being able to claim that the results of a USP <71> sterility test provide evidence of a preparation’s sterility. Method Suitability Testing only needs to be completed once for each compounded formulation, and consists of two parts: i) a suitability test that confirms that the growth media used for sterility testing supports the growth of certain microorganisms and ii) a validation test that demonstrates that no components of the compounded preparation inhibit microbial growth.

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USP <85> Bacterial Endotoxin Testing:

 As bacterial endotoxins can pose health and safety hazards to patients, USP <85> requires bacterial endotoxin testing to detect and quantify the presence of endotoxins from Gram-negative bacteria in sterile compounds. To assure patient safety, the quantity of bacterial endotoxins may not exceed threshold limits defined in USP <85>. For each bacterial endotoxin test, inhibition validation testing is performed. This testing confirms that there are no components of the formulation that will interfere with the bacterial endotoxin test and that the testing used is sensitive enough to provide meaningful, accurate data.

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USP <788> Particulate Count:

Solutions must be essentially free from observable particulate matter. Due to the small amount of material and the heterogenous composition that particulate matter represents, it cannot be quantitated by chemical analysis alone. 

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USP <1207> Container-Closure Integrity Testing:

USP <1207> container-closure integrity testing demosntrates the ability of the container-closure system to maintain the integrity of its microbial barrier throughout the entire shelf-life of a product. Eagle utilizes a pressure decay to test container-closure integrity, which is one of the deterministic methods recommended by USP <1207>. As sterility is an event-related occurrence, container-closure integrity testing is performed to support the claim that the sterile containers in which the preparation is packaged are capable of maintaing the sterility of the product throughout its shelf life. 

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USP <197> Spectroscopic Identification Tests:

Identification by IR USP <197>: This test provides conclusive evidence of the identity of a substance using infrared absorption spectrums compared to a USP reference standard. Conformance with both IR absorption and UV absorption test specifications, as called for in a large proportion of compendial monographs, leaves little doubt, if any, regarding the identity of the specimen under examination.

Identification by UV USP <197>: This test provides the identity of a substance using ultraviolet absorption spectrums compared to a USP reference standard. Conformance with both IR absorption and UV absorption test specifications, as called for in a large proportion of compendial monographs, leaves little doubt, if any, regarding the identity of the specimen under examination.

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USP <643> Total Organic Carbon:

Total Organic Carbon (TOC) is an indirect measure of organic molecules present in pharmaceutical waters measured as carbon. Organic molecules are introduced into the water from the source water, purification and distribution system materials, biofilm growing in the system, and the packaging of sterile and nonsterile waters. TOC can also be used as a process control attribute to monitor the performance of unit operations comprising the purification and distribution system.

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USP <621> Chromatography:

USP <621> Chromatographic separation techniques are multistage separation methods in which the components of a sample are distributed between two phases, of which one is stationary and the other is mobile.  The analytical chromatography methods Eagle utilizes are designed to determine the concentration of the active ingredient(s) in a compounded preparation.  Testing protocols are developed based on guidelines delineated in USP <621> Chromatography and are validated according to USP <1225> Validation of Compendial Procedures and ICH Guidelines. The customer is notified immediately of any sample that does not test within acceptable limits.

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